FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ear, Nose, Throat ×
3,812 results
553–576 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Dec 09, 2013
VENT-OS SINUS DILATION SYSTEM
K133016 · LRC
Sinusys Corporation
Ear, Nose, Throat · 75d
Cleared Dec 02, 2013
NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON...
K130512 · ETB
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 278d
Cleared Nov 22, 2013
OTOMAG BONE CONDUCATION HEARING SYSTEM
K132189 · LXB
Sophono, Inc.
Ear, Nose, Throat · 130d
Cleared Nov 21, 2013
AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO,...
K130514 · KLW
Audifon-USA, Inc.
Ear, Nose, Throat · 267d
Cleared Nov 07, 2013
COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT
K131240 · LXB
Cochlear Americas
Ear, Nose, Throat · 190d
Cleared Nov 06, 2013
SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH
K130357 · BTG
Covidien, LLC
Ear, Nose, Throat · 266d
Cleared Nov 05, 2013
EM SINUS DILATION SYSTEM
K132297 · LRC
Medtronic Xomed, Inc.
Ear, Nose, Throat · 104d
Cleared Nov 01, 2013
AMBU ASCOPE 3 5.0/2.2
K130845 · EOQ
Ambu A/S
Ear, Nose, Throat · 220d
Cleared Oct 31, 2013
INVOTEC LARYNGEAL ELECTRODE
K122040 · ETN
Invotec International, Inc.
Ear, Nose, Throat · 476d
Cleared Oct 18, 2013
PROVOX VEGA PUNCTURE SET
K131947 · EWL
Atos Medical AB
Ear, Nose, Throat · 113d
Cleared Oct 15, 2013
LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)
K131234 · EOQ
Broncus Medical, Inc.
Ear, Nose, Throat · 167d
Cleared Oct 04, 2013
SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT
K131709 · LRC
Arthrocare Corp.
Ear, Nose, Throat · 115d
Cleared Oct 04, 2013
XPRESS MULTI-SINUS DILATION TOOL
K132440 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 59d
Cleared Sep 26, 2013
COCHLEAR BAHA 4 SOUND PROCESSOR
K132278 · LXB
Cochlear Americas
Ear, Nose, Throat · 65d
Cleared Sep 20, 2013
SINUFLUSH LAVAGE SYSTEM
K131177 · KAR
Hedgepath, LLC
Ear, Nose, Throat · 148d
Cleared Sep 17, 2013
BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
K131745 · LFB
Helix Medical, LLC
Ear, Nose, Throat · 96d
Cleared Sep 12, 2013
AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S
K130417 · KLW
Audifon-USA, Inc.
Ear, Nose, Throat · 205d
Cleared Sep 12, 2013
ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI
K132198 · KHJ
Ceremed , Inc.
Ear, Nose, Throat · 58d
Cleared Jul 02, 2013
BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER
K131401 · EOQ
Mercator Medsystems, Inc.
Ear, Nose, Throat · 48d
Cleared Jun 27, 2013
LYRIC2
K130790 · ESD
Phonak, LLC
Ear, Nose, Throat · 97d
Cleared Jun 21, 2013
E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM
K131131 · EOX
Intromedic Co., Ltd.
Ear, Nose, Throat · 60d
Cleared Jun 20, 2013
TITAN
K130795 · EWO
Interacoustics A/S
Ear, Nose, Throat · 90d
Cleared Jun 11, 2013
PATHASSIST LED LIGHT FIBER
K130503 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 104d
Cleared May 29, 2013
MEDIENT MIDDLE TURBINATE IMPLANT
K130354 · LYA
Entrigue Surgical, Inc.
Ear, Nose, Throat · 106d